Cook Pacemaker 216 Bipolar Cardiac

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K841983 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Needle's Eye Snare

  Class II

  FDA 510(k) K961992 Active Cleared 27 Dec 1996

• Model P In-Line Bipolar Endocardial Tined Lead

  Class III

  FDA 510(k) K915188 Active Cleared 11 Sep 1992

• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

  Class III

  FDA 510(k) K853590 Active Cleared 23 Oct 1985

• Model F Unipolar Endocardial Lead

  Class III

  FDA 510(k) K832255 Active Cleared 12 Aug 1983

• Model 325D Unipolar Cardiac Pulse Gen

  Class III

  FDA 510(k) K822904 Active Cleared 15 Oct 1982

• Model 329T Programmable, Bipolar Cardi

  Class III

  FDA 510(k) K832893 Active Cleared 4 Oct 1983

See all devices from Cook Pacemaker Corp. →

• What is the primary clinical purpose of the Cook Pacemaker 216 Bipolar Cardiac, and who should consider using it?

  The Cook Pacemaker 216 Bipolar Cardiac is designed to regulate heart rhythm by delivering electrical impulses to treat patients with bradycardia or other cardiac conduction disorders requiring pacing support. It is intended for single-use implantation by qualified healthcare professionals in patients whose heart rate is too slow or irregular, ensuring consistent pacing when the heart’s natural rhythm fails.

• Is this device reusable, or is it meant for one-time use after implantation?

  This device is explicitly intended for single-use after implantation. The packaging is sterile, and it is not designed or cleared for reuse, ensuring patient safety and compliance with medical device standards.

• How should the Cook Pacemaker 216 Bipolar Cardiac be stored to maintain its integrity?

  The device must be stored in accordance with the manufacturer’s instructions to preserve sterility and functionality. Since it is sterile upon supply, proper storage conditions—such as avoiding contamination, extreme temperatures, or physical damage—are critical to ensure it remains viable for implantation.

• Can this device be used in patients who require MRI scans, or does it pose any risks?

  The Cook Pacemaker 216 Bipolar Cardiac is not MRI-safe, meaning it should not be used in patients who require MRI imaging. The magnetic fields generated during MRI procedures can interfere with or damage the device, posing serious risks to the patient.

• What regulatory pathway was followed for this device’s clearance, and which committee reviewed it?

  This device was cleared through the FDA’s 510(k) pathway under the classification of a Class III medical device, with a Traditional review. It was submitted to the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device, as indicated by the clearance number K841983 and the decision code SESE.